Unique device for determining airway obstructions

• US 8,424,527 B1
• Filed: 09/05/2008
• Issued: 04/23/2013
• Est. Priority Date: 09/05/2008
• Status: Expired due to Fees

• Current Assignee: Cleveland Medical Devices Inc.
• Original Assignee: Cleveland Medical Devices Inc.
• Inventors: Kayyali, Hani, Kolkowski, Brian M.
• Primary Examiner(s): CROW, STEPHEN R
• Application Number:
  US12/231,741
• Time in Patent Office: 1,691 Days
• Field of Search: 128/200.24, 128/206.21, 128/206.22, 128/204.18, 128/204.23
• US Class Current: 128/206.21
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/6819 Nose
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 7/003 Detecting lung or respiration noise
• CPC Class Codes: A61B 8/00 Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00
• CPC Class Codes: A61B 8/08 Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61B 8/4227 characterised by straps, belts, cuffs or braces
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0488 Mouthpieces; Means for guiding, securing or introducing the tubes guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02
• CPC Class Codes: A61M 16/049 Mouthpieces
• CPC Class Codes: A61M 16/0495 with tongue depressors
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means

Abstract

The present invention is related to a device for acoustically monitoring a subject'"'"'s airway to determine airway obstruction(s) and their location(s). The device is particularly useful when performing sleep analysis and sleep therapy, but is also highly useful in determining airway obstructions of any subject when the subject is sleeping or otherwise unconscious, and can further be used in certain applications when the subject is awake or conscious. The device, in its simplest form, is comprised of a supporting body (e.g. a mask, mouthpiece, or nasal cannula) used to position at least one acoustic generator and at least one acoustic sensor at a location essentially proximal to a subject'"'"'s airway, the acoustic generator and acoustic sensor generating and/or sensing sound waves useful in determining obstruction(s) and their location(s) within the airway of a subject.

Claims

1. A mask for acoustic monitoring of obstruction(s) within an airway of a subject comprising:

a mask having a body, the body of the mask capable of essentially conforming to a subject'"'"'s facial features while positioned about the subject'"'"'s mouth and/or nose and;

an acoustic generator and sensor positioned in the mask to be essentially proximal to the subject'"'"'s mouth or nose, the acoustic generator for generating an acoustic signal, and the acoustic sensor for sensing reflections of the acoustic signal as the acoustic signal is reflected by structures in the subject'"'"'s upper airway to determine the location of an obstruction within a subject'"'"'s upper airway;

wherein the acoustic generator and the acoustic sensor are comprised of a single acoustic transducer capable of both generating and sensing sound waves.

2. The device of claim 1 wherein said mask further includes vents, ports or airways to allow the subject to breathe regularly while wearing said mask.

3. The device of claim 1 wherein said mask further includes a point of connection to an air hose attached to a continuous positive airway pressure device.

4. The device of claim 1 wherein the acoustic generator and the acoustic sensor are electronically connected to, and/or controlled by a continuous positive airway pressure device, or sleep disorders diagnostic equipment.

5. The device of claim 1 wherein the mask is a face mask, covering both the mouth and nose of the subject.

6. The device of claim 1 wherein the mask is a nose mask, covering only the nose of the subject.

7. The device of claim 1 wherein the mask is an oral mask, covering only the mouth of the subject.

8. The device of claim 1 wherein the single acoustic transducer comprises a piezoelectric acoustic transducer.

9. The device of claim 1 wherein the single acoustic transducer comprises a pressure-sensitive diaphragm connected to appropriate electrical components to allow the diaphragm to both generate an acoustic signal and sense reflections of the generated acoustic signal.

10. A system for acoustic monitoring of obstructions in a subject'"'"'s upper airway, the system comprising:

a mask, the mask comprising a mask body capable of essentially conforming to a subject'"'"'s facial features, at least one acoustic generator and at least one acoustic sensor integrated into the mask, the at least one acoustic generator for generating an acoustic signal, and the at least one acoustic sensor for sensing reflections of the acoustic signal as the acoustic signal is reflected by structures in the subject'"'"'s upper airway to determine the location of an obstruction within a subject'"'"'s upper airway;

wherein the acoustic generator and the acoustic sensor are comprised of a single acoustic transducer capable of both generating and sensing sound waves; and

a sleep diagnosis device connected to the acoustic generator and acoustic sensor of the mask for generating signals to be output by the acoustic generator and for receiving and storing reflected acoustic signals sensed via the acoustic sensor.

11. The system of claim 10 wherein the sleep diagnosis device is further capable of analyzing the acoustic signals output by the acoustic generator and the reflected acoustic signals sensed by the acoustic sensor to determine a location of an obstruction in the subject'"'"'s upper airway.

12. The system of claim 10 wherein the mask is a face mask that covers both the mouth and nose of the subject.

13. The system of claim 10 wherein the single acoustic transducer comprises a pressure-sensitive diaphragm connected to appropriate electrical components to allow the transducer to both measure and produce sound waves.

14. The system of claim 10 wherein the single acoustic transducer comprises a piezoelectric acoustic transducer.

15. A method of monitoring obstructions within a subject'"'"'s upper airway while the subject sleeps, the method comprising:

placing a mask on a subject'"'"'s face, the mask comprising a mask body capable of essentially conforming to a subject'"'"'s facial features, at least one acoustic generator for generating an acoustic signal and at least one acoustic sensor for sensing reflections of the generated acoustic signal;

connecting the at least one acoustic generator and the at least one acoustic sensor to a sleep diagnosis device capable of generating signals to be output by the acoustic generator and receiving and storing reflected acoustic signals sensed via the acoustic sensor while the subject sleeps; and

analyzing the generated and reflected acoustic signals to determine the location of an obstruction within a subject'"'"'s upper airway;

wherein the acoustic generator and the acoustic sensor are comprised of a single acoustic transducer capable of both generating an acoustic signal and sensing reflections of the generated signal.

16. The method of claim 15 wherein the mask is a face mask that covers both the mouth and nose of the subject.

17. The method of claim 15 wherein the step of analyzing is performed automatically by a computer.

18. The method of claim 15 wherein the single acoustic transducer comprises a pressure-sensitive diaphragm connected to appropriate electrical components to allow the diaphragm to both measure and produce sound waves.

19. The method of claim 15 wherein the single acoustic transducer comprises a piezoelectric acoustic transducer.